Hatch-Waxman litigation with generic manufacturers has long been the focus of competition involving traditional small molecule drugs. The litigation between Amgen and Sanofi regarding large molecule next-generation cholesterol drugs, however, illustrates the new prominence of innovator vs. innovator litigation in the pharmaceutical industry. In these types of cases, the law of written description looms large because innovators might try to cover all possible drugs that focus on a biologic target while disclosing only a few examples of a possibly large genus.
The recent Federal Circuit opinion in Amgen v. Sanofi, reversing Amgen’s district court win, will have a significant impact from R&D labs to court rooms. The Federal Circuit vacated a district court’s finding that Amgen’s claims for a genus of monoclonal antibodies were not invalid and a permanent injunction enjoining sales of Sanofi’s Praluent®- and remanded for a new trial.
The Federal Circuit also made new law that will influence pharma litigation outside of antibodies. The district court had excluded evidence about Sanofi and co-defendant Regeneron’s own products. The district court excluded the post-priority evidence because it “did not illuminate the state of the art at the time of filing.” The Federal Circuit, by contrast, explained that evidence showing that species disclosed in a patent are not representative of a claimed genus is in fact likely to postdate the priority date, and is able to prove inadequate written description.
Our panel includes the biotech counsel of a multinational innovator company, and two top litigators. They will discuss:
- What is now needed by way of written description to create a valid patent on an antibody? The entire DNA sequence? Just the CDRs? The entire 3D structure?
- How does Amgen v. Sanofi clarify the law beyond earlier cases such as Abbvie v. Janssen and Ariad v. Lilly?
How will pharma litigation change after the case, and how will it affect specific pending cases including challenges on Amgen’s Embrel®?
Speakers:
- Jane Love, Gibson, Dunn & Crutcher LLP
- Duane Marks, Eli, Lilly & Company
- Irena Royzman, Patterson Belknap Webb & Tyler LLP
